Abstract
568 Background: Capecitabine (cape) associated hand-foot syndrome (HFS) has been previously reported to be a clinical predictor of improved survival or disease control in metastatic colorectal cancer (mCRC) and breast cancer. This study evaluates the relationship between degree of HFS and objective tumor response in patients (pts) receiving capecitabine and sorafenib (sor) for mCRC as part of an ongoing clinical trial. Methods: Pts with refractory mCRC treated on phase II prospective study with SorCape (NCT01471353) were eligible. 24 of 43 planned pts have been enrolled and all are assessable. Adverse events (AEs) related to HFS were graded by CTACE v4 during the first 3 cycles of therapy and scored as mild (graded 0 or 1), moderate (mod) (grades 2 or 3) or severe (grade 4). Independent RECIST criteria measurements of target tumor volumes were recorded with maximal volumetric regression or progression noted. The correlation between degree of HFS and objective RECIST response was analyzed. Results: Total cohort pt demographics and tumor characteristics are presented separately. 5 (21%) had mild HFS and 19 (79%) developed mod HFS. No pts had severe HFS. Baseline characteristics including age were similar in both groups. Univariate analysis showed no significant correlation between KRAS mutational status, baseline serum CEA, or LDH levels. Pts with mild HFS had a mean 25% (1-68% regression) tumor regression compared to a 20% progression (22% regression to 80% progression) with moderate HFS (p=0.046). Progression free and overall survival data are immature for analysis. Conclusions: In this exploratory analysis of an ongoing clinical trial, the degree of HFS negatively correlated with objective tumor response. The combination of overlapping HFS AEs with this specific dual therapy may impact the previously reported clinical predictor. Ongoing patient enrollment and further analysis of this clinical observation is planned. Clinical trial information: NCT01471353.
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